Validation Specialist I - Instrument & Assay Quality

Kaiser Permanente; Rockville (MD); On-site; USD 100,000 - 150,000; Full time

Job summary

Kaiser Permanente in Rockville, MD seeks an experienced laboratory leader to oversee testing activities, validation, calibration, and quality assurance. You will collaborate across departments, develop training programs, and ensure regulatory compliance while supporting assay development and instrument performance.

The role requires leadership experience in healthcare, strong problem solving, and a commitment to quality and patient safety within a fast-paced clinical laboratory environment.

Qualifications

• Minimum two (2) years of experience working in a laboratory environment.
• Minimum one (1) year of experience in a leadership role within a healthcare related field.
• Bachelor's degree in medical lab science or equivalent, or health care related field AND minimum four (4) years of experience in medical technology, clinical laboratory sciences, or health care related field OR minimum seven (7) years of experience in medical technology, clinical laboratory sciences, or health care related field.

Responsibilities

• Performs initial testing and setup procedures for new or replaced instruments (validation, verification, calibration, sensitivity studies).
• Supports assay development and contributes to validation plans implementation and performance.
• Maintains testing and training standards by developing materials and delivering training; evaluates personnel competency; identifies training needs and ensures ongoing training.
• Maintains compliance and accreditation by aligning policies with regulations and inspection checklists; manages recruitment, processing, testing, storage and distribution procedures; updates documentation.

Skills

Ambiguity management

Attention to Detail

Communication

Leadership

Problem Solving

Quality Assurance

Team Leadership

Regulatory Knowledge

Training & Development

Education

Bachelor's degree in medical lab science or equivalent, or health care related field, plus 4+ years of experience OR 7+ years of experience in medical technology/clinical lab sciences

Job description

Kaiser Permanente in Rockville, MD seeks an experienced laboratory leader to oversee testing activities, validation, calibration, and quality assurance. You will collaborate across departments, develop training programs, and ensure regulatory compliance while supporting assay development and instrument performance.

The role requires leadership experience in healthcare, strong problem solving, and a commitment to quality and patient safety within a fast-paced clinical laboratory environment.